EUCTR2018-002896-17-IT进行中（未招募）1 期
A Multicenter, Open-Label, Single-Arm, Phase 2 Study of ME-401 in Subjects with Follicular Lymphoma After Failure of Two or More Prior Systemic Therapies - Not applicable
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age = 18 years (or age of majority)
- •2. Histologically confirmed diagnosis of FL as defined in the WHO classification scheme, limited to Grade 1, 2, or 3a
- •3. Subjects with relapsed or refractory FL who received =2 prior therapy regimens. A previous regimen is defined as one of the following: at least two months of single-agent therapy or at least two consecutive cycles of polychemotherapy, autologous transplant, or radioimmunotherapy. Prior therapy must include rituximab and an alkylating agent(s). Relapsed or refractory disease defined as:
- •a. Relapsed disease: disease progression after a response (CR or PR) lasting =6 months
- •b. Refractory disease: no response to therapy (no CR or PR) or response lasting <6 months
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. Histologically confirmed FL Grade 3b, or transformed disease (assessed by the Investigator):
- •a. Histological confirmation of transformation, or
- •b. Clinical and laboratory signs: rapid disease progression, high standardized uptake value (>12) by positron emission tomography (PET) at baseline
- •2. Known lymphomatous involvement of the central nervous system.
- •3. Major surgical procedure within 4 weeks prior to study Day 1
- •4. Prior therapy with PI3K inhibitors.
- •5. Any uncontrolled clinically significant illness including, but not limited to, active infections requiring systemic antimicrobial therapy, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction
- •6. Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B core antibody plus have a positive hepatitis B PCR assay; subjects with a negative PCR assay are permitted with appropriate anti-viral prophylaxis
- •7. Positive HCV Ab; subjects with positive hepatitis C antibody are eligible if they are negative for HCV by PCR.
- •8. Known history of, or active HIV infection.
- •9. Ongoing or history of drug-induced pneumonitis
- •10. Previous or concurrent cancer that is distinct in primary site or histology from indolent B-cell NHL within 3 years before start of study treatment except for curatively treated cervical cancer in situ, nonmelanoma skin cancer, and superficial bladder tumors (Ta [non-invasive tumor], Tis [carcinoma in situ], and T1 [tumor invades lamina propria]).
- •11. History of clinically significant cardiovascular abnormalities such as congestive heart failure (New York Heart Association classification = II [NYHA 1994]), myocardial infarction within 6 months of study entry.
- •12. History of clinically significant gastrointestinal (GI) conditions, particularly:
- •a. Known GI condition that would interfere with swallowing or the oral absorption or tolerance of study drug
- •b. Pre-existing malabsorption syndrome or other clinical situation that would affect oral absorption
- •13. Females who are pregnant; females who plan to breastfeed during study treatment through 90 days after ending treatment.
- •14. Psychiatric illness/social situations that would interfere with study compliance.
- •15. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients.
研究者
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